Apomorphine Effects on Experimental Pain

NCT ID: NCT01744964

Last Updated: 2016-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-07-31

Brief Summary

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The aims of this study were to assess the effects of the dopamine agonist apomorphine on experimental pain models in healthy subjects and to explore the possible association between these effects and a common polymorphism within the dopamine transporter gene.

Detailed Description

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Healthy volunteers (n=105) participated in this randomized double-blind, placebo-controlled, cross-over trial. Heat pain threshold and intensity, cold pain threshold, and the response to tonic cold pain (latency, intensity, and tolerance) were evaluated before and for up to 120 min after the administration of 1.5 mg apomorphine/placebo. A polymorphism (DAT-1) within the dopamine transporter gene (SLC6A3) was investigated.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Saline

Assessment of experimental pain models before and after treatment

Group Type PLACEBO_COMPARATOR

Apomorphine

Intervention Type DRUG

1.5 mg Apomorphine

Apomorphine

Assessment of experimental pain models before and after treatment

Group Type ACTIVE_COMPARATOR

Apomorphine

Intervention Type DRUG

1.5 mg Apomorphine

Interventions

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Apomorphine

1.5 mg Apomorphine

Intervention Type DRUG

Other Intervention Names

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Active Comparator: Apomorphine

Eligibility Criteria

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Inclusion Criteria

\- healthy and free from chronic pain of any type did not use any medications other than oral contraceptives were able to understand the purpose and instructions of the study.

Exclusion Criteria

\- any type of medical or painful condition use of medications or recreational drugs pregnancy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elon Eisenberg, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus, Haifa, Israel

Locations

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Rambam Health Care Campus

Haifa, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0078-09-RBM

Identifier Type: -

Identifier Source: org_study_id

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